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Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929590
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Felix Tellez, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:
the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments are not different.

Condition or disease Intervention/treatment Phase
Bowel Preparation for Colonoscopy Drug: PEG-3350 group 2 Drug: PEG-3350 group 1 Drug: PEG-3350 group 3 Phase 3

Detailed Description:

In-hospital patients were randomly assigned to one of three groups: group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am).

The quality of colonic preparation was assessed by the Boston bowel preparation scale (13); tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and adverse effects in group 3 were compared with those in groups 1 and 2. The time since the last dose of bowel-preparation agent, the time since the last solid food was consumed, the approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of the colonoscopy were recorded.

Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Efficacy and Tolerability of Low-volume Polyethylene Glycol (2 L) vs. Single- (4 L) vs. Split-dose (2L + 2L) of Polyethylene Glycol Bowel Preparation for Colonoscopy: a Randomized Clinical Trial.
Study Start Date : October 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: PEG-3350 group 3
group 3: low-volume 2 L PEG-3350 solution (same day of the procedure 06:00-08:00 am).
Drug: PEG-3350 group 3
low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)
Other Name: Nulytely

Active Comparator: PEG-3350 group 1
group 1 single dose (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h)
Drug: PEG-3350 group 1
PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h
Other Name: Nulytely

Experimental: PEG-3350 group 2
group 2: split-dose (PEG-3350 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
Drug: PEG-3350 group 2
split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
Other Name: Nulytely




Primary Outcome Measures :
  1. satisfactory bowel preparation [ Time Frame: at the moment of colonoscopy ]
    The aim of this study was to test the quality of bowel preparation and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to single (4 L) or split-dose (2 L + 2 L) treatments. The quality of colonic preparation was assessed by the Boston bowel preparation scale.Satisfactory colon preparation was considered when scores of the Boston bowel preparation scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.


Secondary Outcome Measures :
  1. tolerability with bowel preparation [ Time Frame: just before to start the colonoscopy and before any sedative be administered ]
    tolerability of bowel preparation was measured, considering: nausea, vomiting, and abdominal pain, compliance, sleep disturbance and adverse effects.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In-hospital patients with an indication for colonoscopy

Exclusion Criteria:

  • patients under 18 years of age
  • the presence of a severe illness (cardiac, renal, or metabolic)
  • major psychiatric illness
  • known allergies to PEG-3350
  • refusal to consent to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929590


Locations
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Mexico
Instituto Nacional de ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Distrito Federal, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Felix Téllez-Ávila, Ph.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publications:

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Responsible Party: Felix Tellez, Ph.D., Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01929590    
Other Study ID Numbers: end-407-11-11-1
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Felix Tellez, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Colonoscopy
Preparation
Polyp
Polyethylene glycol
Additional relevant MeSH terms:
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Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents